The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease. This study adopts an event-driven design and ends when the target number of the primary endpoint event is reached.
Diagnosed with atherosclerotic cardiovascular disease (ASCVD)
The body mass index (BMI) at the time of screening was ≥24.0 kg/m ². Patients with type 2 diabetes have a BMI of ≥22.0 kg/m ²
Screening for myocardial infarction, acute decompensated heart failure, hospitalization due to heart failure, unstable angina pectoris, stroke or transient ischemic attack, coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, carotid or peripheral artery recanalization within 30 days prior to the screening
Severe hypoglycemic events or recurrent hypoglycemic events occurred within one month before screening
When screening, there are proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers
Coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, and carotid or peripheral artery recanalization are planned to be performed during the trial
Parallel
HRS9531
DrugHRS9531 Dose 1 , subcutaneous injection
HRS9531 placebo
DrugHRS9531 placebo Dose 1, subcutaneous injection
The time from randomization to the first occurrence of the MACE-3 composite endpoint
Time to the first occurrence of the MACE-4 composite endpoint
Time to the first occurrence of the extended MACE composite endpoint
Time to the first occurrence of the composite endpoint of heart failure；
Time to the first occurrence of the composite endpoint of kidney disease；
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